Results of a multicenter randomized study to evaluate the safety and efficacy of combined immunotherapy with interleukin-2, interferon-{alpha}2b and histamine dihydrochloride versus dacarbazine in patients with stage IV melanoma.

Journal article

BACKGROUND: The safety and efficacy of immunotherapy with histamine dihydrochloride (HDC), interleukin-2 (IL-2) and interferon-alpha2b (IFN) compared with dacarbazine (DTIC) in adult patients with stage IV melanoma was evaluated. PATIENTS AND METHODS: Two hundred and forty-one patients were randomized to either receive repeated 4-week cycles of IFN [3 MIU, s.c., once daily for 7 days], IL-2 (2.4 MIU/m(2), s.c., twice a day for 5 days) and HDC (1 mg, s.c., twice a day for 5 days) or DTIC 850 mg/m(2) i.v. every 3 weeks. The primary endpoint was overall survival. RESULTS: Median survival was longer for patients receiving HDC/IL-2/IFN (271 days) than for patients receiving DTIC (231 days), but this did not achieve statistical significance. Four patients receiving HDC/IL-2/IFN and nine receiving DTIC experienced at least one grade 4 adverse event. Striking differences in overall survival were observed between countries participating in the study. CONCLUSION: Treatment with HDC/IL-2/IFN was safely administered on an outpatient basis, but this immunotherapeutic regimen did not improve upon the response rate and overall survival seen with DTIC.

Authors: Middleton, M; Hauschild, A; Thomson, D; Anderson, R; Burdette-Radoux, S

• Publication status: Published
• Journal: Annals of oncology : official journal of the European Society for Medical Oncology / ESMO
• Volume: 18
• Issue: 10
• Pages: 1691-1697
• Publication date: 2007-10-01
• DOI: 10.1093/annonc/mdm331
• EISSN: 1569-8041
• ISSN: 0923-7534
• Language: English
• Keywords: Histamine; Adult; Interferon Alfa-2b; Multivariate Analysis; Aged; Immunotherapy; Neoplasm Staging; Female; Middle Aged; Antineoplastic Combined Chemotherapy Protocols; Humans; Dacarbazine; Melanoma; Interleukin-2; Male